Safety needle system operable with a medical device

ABSTRACT

A safety needle system operable with a medical device includes: a housing with a needle mount having a needle; and a sheath telescopically engaged with the housing and surrounding the needle such that the sheath operates in a retracted position, in which the sheath exposes the needle, and an extended position, in which the sheath surrounds the needle. The sheath is coupleable to the medical device such that removal of the needle from the medical device draws the sheath over the needle, transitioning the sheath from the retracted position to the extended position. In one embodiment, the system includes a slider engaged with the sheath and/or housing and including a restraint that engages and disengages the sheath to respectively reinforce and weaken the coupling of the sheath and medical device. In another embodiment, the sheath includes a longitudinal track that slidingly engages a setting of the housing between sheath positions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/111,716, filed 19 May 2011, which claims the benefit of U.S.Provisional Applications Nos. 61/352,220 filed 7 Jun. 2010, 61/407,777filed 28 Oct. 2010, 61/448,132 filed 1 Mar. 2011, 61/346,292 filed 19May 2010, 61/407,797 filed 28 Oct. 2010, 61/418,354 filed 30 Nov. 2010,61/438,781 filed 2 Feb. 2011, and 61/442,456 filed 14 Feb. 2011, theentirety of all of which is incorporated in their entirety by thisreference.

TECHNICAL FIELD

This invention relates generally to the medical field, and morespecifically to an improved safety needle system in the medical field.

BACKGROUND

Many medical devices, such as catheter systems for establishingintravenous therapy, include needles that are inserted into patients. Bycontacting body tissue and fluids such as blood, such needles carrybiohazard risks including cross-contamination and transmission ofblood-borne diseases, as well as accidental needle sticks or puncturesinflicted on a user of the medical device or any other handlers of usedmedical instruments. Thus, there is a need in the medical field tocreate an improved safety needle system. This invention provides such animproved safety needle system operable with a medical device.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A and 1B are schematics of the safety needle system of a firstpreferred embodiment with the sheath in the retracted position and inthe extended position, respectively;

FIGS. 2A-2C are schematics of the housing in the safety needle system ofa first preferred embodiment;

FIGS. 3A-3D are schematics of variations of interactions between thehousing and the slider in the safety needle system of a first preferredembodiment;

FIG. 4 is an “unwrapped” illustration of the housing stop in the safetyneedle system of a first preferred embodiment;

FIG. 5 is an example of the safety needle system in use with a medicaldevice;

FIGS. 6A-6C are variations of the needle in the safety needle system ofa preferred embodiment;

FIGS. 7A-7F are schematics of the sheath in the safety needle system ofa first preferred embodiment;

FIGS. 8A-8F are schematics of the slider in the safety needle system ofa first preferred embodiment;

FIGS. 9A-9B and 10A-10B are schematics of variations of the sheath inthe safety needle system of a first preferred embodiment;

FIGS. 11A-11C are schematics of the coupling between the sheath, slider,and housing during use of the safety needle system of the firstpreferred embodiment;

FIGS. 12A and 12B are schematics of the “closed” and “open”configurations of the jaws in the sheath of a variation of the safetyneedle system of the first preferred embodiment;

FIGS. 13A-13F are schematics of a variation of the slider in the safetyneedle system of a first preferred embodiment;

FIGS. 14A and 14B are schematics of the safety needle system of a secondpreferred embodiment with the sheath in the retracted position and inthe extended position, respectively;

FIGS. 15A-15C are schematics of a perspective view, cross-sectionalperspective view, and cross-sectional side view, respectively, or thehousing in the safety needle system of a second preferred embodiment;

FIGS. 16A-18B are schematics of variations of the sheath in the safetyneedle system of a second preferred embodiment;

FIGS. 19A-20D are schematics of variations of the locking mechanism inthe safety needle system of a second preferred embodiment;

FIGS. 21A-22B are schematics of the method of assembling the safetyneedle system of a second preferred embodiment;

FIGS. 23-26B are schematics of the safety needle system of a preferredembodiment with a septum;

FIGS. 27A-31E are schematics of septum variations in the safety needlesystem of a preferred embodiment;

FIG. 32 is a schematic of a housing with vent chamber in the safetyneedle system of a preferred embodiment;

FIGS. 33A and 33B are schematics of catch variations in the safetyneedle system of a preferred embodiment; and

FIGS. 34A-40B are schematics of the steps of the method of using thesafety needle system of a preferred embodiment.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of preferred embodiments of the invention isnot intended to limit the invention to these preferred embodiments, butrather to enable any person skilled in the art to make and use thisinvention.

The safety needle system is preferably used with a catheter with acatheter hub, such as an intravenous catheter. In one embodiment, thesafety needle system is operated with a vascular delivery system such asthat described in U.S. patent application Ser. Nos. 12/855,013 and13/111,693, which are each hereby incorporated in its entirety by thisreference. In particular, the safety needle system may be operable witha vascular delivery system adapted to be placed about a catheterinsertion site on a patient, in which the vascular delivery systemincludes a frame with a catheter hub providing a first anchoring pointon the patient, a stabilization hub providing a second anchoring pointon the patient, and at least one lateral member extending between thecatheter hub and the stabilization hub, such that the first and secondanchoring points are distributed around the insertion site to anchor theframe to the patient and stabilize the catheter. However, the safetyneedle system may alternatively be used with any other suitable kind ofcatheter, a syringe, or other medical needle devices or devices usedwith a medical needle. Use of the safety needle system with such medicaldevices may reduce risk of cross-contamination and infection from bodilyfluids and other biohazards, and reduce risk of accidental needleinjuries to a user handling the medical device.

Safety Needle System of a First Embodiment

In a first preferred embodiment, as shown in FIGS. 1 and 2, the safetyneedle system 100 operable with a medical device 102 includes: a housingno having a needle mount 112; a needle 120 having a distal endinsertable through the medical device 102 and a proximal end coupled tothe needle mount 112; a sheath 130 telescopically engaged with thehousing no and circumferentially surrounding at least a portion of theneedle 120, in which the sheath 130 operates in a retracted position 132and an extended position 134; and a slider 150 longitudinally engagedwith the sheath and/or housing and including a restraint thatselectively engages with the sheath. In the retracted position 132 ofthe sheath, the sheath exposes the distal end of the needle. In theextended position of 134 of the sheath, the sheath substantiallysurrounds the distal end of the needle. The sheath is coupleable to themedical device such that removal of the needle from the medical devicedraws the sheath over the needle, thereby transitioning the sheath fromthe retracted position to the extended position. In a preferredembodiment, the restraint is selectively engaged with the sheath suchthat (1) the restraint is coupled to the sheath when the sheath is inthe retracted position and coupled to the medical device, and therestraint reinforces the coupling of the sheath to the medical device,and (2) the restraint is uncoupled from the sheath when the sheath is inthe extended position, and the restraint weakens the coupling of thesheath to the medical device, thereby reducing the force required touncouple the sheath from the medial device. In other variations, duringremoval of the needle from the medical device as the sheath is drawnover the needle, the slider automatically triggers the full uncouplingof the sheath and the medical device. Removal of the needle ispreferably performed by pulling the needle away from the medical device,but alternatively removal of the needle may be performed by pulling themedical device away from the needle. In other words, to draw the sheathfrom its retracted position to its extended position and to decouple thesafety needle system from the medical device, the user (e.g., medicalpractitioner) may pull the needle away in a proximal direction (or pullthe medical device away in a distal direction away from the safetyneedle system) thereby allowing the sheath to slide from its retractedposition to its extended position to cover the distal end of the needle.In a preferred embodiment, the slider further includes a proximalarticulation and a distal articulation, When the sheath is in theextended position the proximal articulation is coupled to the housingand the distal articulation is coupled to the sheath, thereby lockingthe sheath in the extended position; however, the system may include anysuitable locking mechanism to lock the sheath in the extended position.

The housing 110 functions to support the sheath 130 and the slider 150,to support the needle and/or to provide a user interface. As shown inFIGS. 2A-2C, the housing 110 includes a needle mount 112 to which theneedle is coupled. The needle mount is preferably on a distal end of thehousing and axially centered on the housing, but may alternatively be onany suitable portion of the housing. The needle may be molded into theneedle mount such that the distal end of the needle extends out of thedistal end of the housing, but the needle may alternatively be coupledto the needle mount with a snap fit, friction fit, threads, epoxy, or inany suitable manner.

The housing 110 is slidingly or telescopically engaged with the sheath130 and/or slider 150. The housing no includes an inner portion that iscontained within the sheath, such that the housing slides within thesheath. However, alternatively the housing may be tubular or otherwiseconfigured such that the sheath slides within the housing. The innerportion of the housing may include a track 114 along which the slider150 is slidingly engaged. The track is preferably longitudinal along thehousing body, and may be a projected track such as a ridge (FIGS. 3A and3D), and/or a recessed track (FIGS. 3B-3D). In one variation, as shownin FIG. 3A, the housing includes one or more arches 118 that form anouter framework around the sheath and/or slider, such as brackets.

The housing 110 preferably includes a housing stop 116 that isconfigured to abut the proximal articulation of the slider 150 when thesheath is in the extended position. In a preferred embodiment, theabutment of the housing stop 116 against the proximal articulation 164(or other portion of the slider) functions to fix the relative positionsof the housing and slider, thereby contributing to locking the sheath inthe extended position. In one variation, as best shown in FIGS. 2C and4, the housing stop 116 includes a snap lock cantilevered arm whose freeend abuts the proximal articulation of the slider. The housing stop 116may be biased or radially deflected towards the slider such as to allowthe slider to pass the housing stop in one direction (e.g. as the sliderpasses in a distal direction relative to the housing) but to prevent theslider from passing the housing stop in the opposite direction (e.g. asthe slider passes in a proximal direction relative to the housing).Alternatively, other housing stop may include a sliding latch, lever,push button, another protrusion of the housing that interacts with theslider, or another suitable mechanism that abuts any suitable portion ofthe slider. As another alternative, the housing stop may include anaperture that receives the proximal articulation or any suitable portionof the slider. The housing stop is preferably integrally formed with thehousing, but may alternatively be a separate piece coupled to thehousing during assembly of the safety needle device.

In some embodiments, as best shown in FIG. 1, the housing 110 may haveone or more handles 111 that a user can grip and manipulate to operatethe safety needle system. The handle 111 preferably includes two sidegrips on opposite sides of the housing that enable secure grasping withone hand. The handle 111 may include features such as ergonomiccontours, ridges to improve friction in the grip, cushioning materialsuch as silicone, or any suitable additions. Furthermore, othervariations of the handle may include fewer or more grips (such as asingle bulbous handle), and may be particular for specific applications.In some embodiments, as shown in FIG. 5, the handle may further functionas a hub cradle, such as for receiving a catheter hub or stabilizationhub such as that described in U.S. patent application Ser. No.12/855,013, or any suitable hub or other portion of a medical device.

The housing 110 is preferably plastic and may be made of one singularpiece, such as by an injection molding that forms the needle mount,arches, and/or handles integrally with the rest of the housing. Thehousing may alternatively include multiple pieces that are separatelymanufactured and attached to the tubular portion of the housing in asecondary process such as with adhesive, locking joints, or otherfasteners. However, the housing may be in made in any suitablemanufacturing process such as milling, turning, or stereolithography,and be made of any suitable material.

The needle 120 of the safety needle system is preferably a medical gradeneedle with a cannula, such as those used to aid insertion of catheters.The needle may have a gauge or size that is selected from a group ofavailable needle gauges, such as standard diameter sizes. In onevariation, as shown in FIG. 6A, the needle 120 may include a notch 122along a portion of the length of the needle. The notch 122 is positionedat a notch extent distance 126 defined as the distance between thedistal end of the needle and the proximal edge of the notch. In anexemplary embodiment used with a catheter, during catheter placementwithin a blood vessel, the needle 120 is typically telescopicallyengaged within the catheter, forming an annular space between the outerwall of the needle and inner wall of the catheter. When the needle isplaced within the blood vessel, blood or other fluids pass along thelength of the needle, and the notch in the needle allows a small amountof the fluid (known as “flash”) to pass into the annular space betweenthe needle and catheter. This “flash” becomes visible to the userthrough the catheter, and the appearance of the flash signifies needleplacement within the blood vessel.

In another variation of the needle 120, as shown in FIG. 6B, the needlemay be a substantially solid needle rather than a hollow needle with acannula. For example, the needle 120 may include a trocar as a catheterintroducer. In this variation, the needle may include a sharp distal tipand a groove running from the distal tip of the needle. The groove 124preferably receives the flash upon needle insertion into the vessel(FIG. 6C), and the flash may be visible to the user through the cathetertubing and/or catheter hub.

The sheath 130 of the safety needle system preferably functions to coverthe distal end of the needle 120 after the needle tip is no longerneeded, to help protect the user from fluid contamination and accidentalneedle punctures. The sheath 130 operates in a retracted position 132and an extended position 134, such that in the retracted position 132the sheath exposes the distal end of the needle 120, and in the extendedposition 134 the sheath is extended from the housing and substantiallysurrounds or covers the distal end of the needle 120. In the extendedposition, the sheath may cover the entire needle body, or only a portionof the needle body including the distal end.

As best shown in FIG. 7F, the sheath 130 preferably includes a set ofsheath stops including a first stop 136 and a second stop 137. The firststop 136 is configured to abut the distal articulation of the slider 150when the restraint 151 is engaged with the split portion 140 of thesheath. The second stop 137 is configured to abut the distalarticulation of the slider 150 when the sheath is in the extendedposition which prevents substantial relative longitudinal motion of thesheath and housing, thereby contributing to locking the sheath in theextended position. The sheath stops may additionally and/oralternatively abut against any suitable part of the slider. In onevariation the sheath stops 136 and 137 may include an aperture definedin a side wall of the sheath. The aperture may have a partial perimeterdefined by the gap between two or more split portions 140 in a side wallof the sheath. For example, the split portions 140 may be opposingmembers with each member having an angled or toothed tip 142. Theopposing angled tips 142 define an aperture with a surface for abuttingthe distal articulation of the slider. Alternatively, the aperture maybe a hole with an enclosed perimeter defined in the side wall of thesheath. In other variations, the sheath stops may include a projectionor other extension, such as one similar to any of the variations of thehousing stop, on any suitable portion of the sheath.

The sheath 130 may include a mating feature that enables the sheath tocouple to the medical device. In one variation, the distal end of thesheath is adapted to mechanically couple to the medical device. In onepreferred embodiment, as shown in FIGS. 7A-7E, the mating featureincludes jaws 142 extending longitudinally from a distal end of thesheath 130. The jaws 142 are preferably flexible and couple tocorresponding mating features (e.g., external articulations, cutouts orpockets) on the medical device 102. Each jaw may be coupled to a splitportion 140 of the distal end of the sheath, and preferably couples tothe restraint tab 151 of the slider. For example, as shown in FIG. 8F,each split portion or jaw may define a restraint slot 138 that receivesa respective restraint tab 151 of the sheath. In one variation, the jawsmay have an approximately arcuate profile (FIG. 7A) to conform to anapproximately circular portion of the medical device. In othervariations, the jaws may include hooked tips 144 (FIGS. 9A and 10B)and/or platforms 146 (FIGS. 10A and 10B) configured to particularcorresponding features on the medical device 102 and/or slider 150. Inother variations of mechanically coupling to the medical device, thesheath 130 may extend beyond the distal end of the housing when thesheath is in the retracted position to enable the distal end of thesheath to seat within a channel (e.g. a septum or other receptacle) ofthe medical device. For example, the medical device may retain thedistal end of the sheath. As another example, the distal end of thesheath 130 may include extensions that mate with a corresponding recessin the medical device, or the medical device may include extensions thatmate with a corresponding recess on the sheath 130. The distal end ofthe sheath 130 may include other features for sating within the septumor another receiving portion of the medical device, such as having aslight taper to a narrower diameter that fits within the septum,frictional features like ribs or ridges that may includes retention ofthe sheath 130 within the septum. The distal end of the sheath mayadditionally and/or alternatively couple to the medical device withmagnets, adhesive, snap locks, fasteners, or any suitable mechanicalmeans.

In another variation, the distal end of the sheath 130 is adapted tomanually couple to the medical device 102. For example, as shown in FIG.7A, the sheath may include a holding tab 148 extending from the distalend of the sheath that provides a finger rest for the user to press theholding tab against the medical device, thereby manually coupling thesheath and the medical device. The holding tab may extend laterallyoutwards or be a projection from the sheath extending in any suitabledirection. The holding tab 148 may provide assistance for the user tohold the sheath against the medical device as a counterforce whilepulling the housing and needle 120 away from the medical device. Asshown in FIG. 7D, the holding tab 148 may include a bridge that connectsthe split portions of the sheath stop. Alternatively, the sheath mayinclude multiple holding tabs, such as one holding tab 148 extendingfrom each split portion 140 or jaw 142 of the sheath. The holding tab148 may include features to help the user hold the holding tab againstthe medical device, such as a lip, ridges that increase friction, or afriction coating such as silicone. The holding tab may include adhesiveand/or a mechanical attachment such as a pin, snap or latch that couplesthe holding tab to the medical device.

In a preferred embodiment, the slider 150 functions to selectivelymodulate the coupling force between the sheath and the medical device.The slider 150 may further contribute to locking the sheath 130 in theextended position over the distal end of the needle 120. The slider 150longitudinally extends along at least a portion of the sheath 130 and/orhousing and is slidingly engaged with the sheath and/or housing, suchthat the housing, sheath and slider are longitudinally movable relativeto one another. The slider 150 may be directly coupled to the sheath,housing, needle, or any suitable portion of the system. As shown inFIGS. 8A-8E, the slider 150 may include a planar portion 152 and asheath insert portion 143. The planar portion is preferablysubstantially flat and is slidingly engaged with the track of thehousing, although may alternatively be contoured. The planar portion 152may include a groove 156 (FIG. 3A) and/or a ridge 158 (FIG. 3B)complementary to the track 114 of the housing no, or any suitableprofile. The sheath insert portion 154 is preferably located on a distalsection of the slider, and is telescopically engaged in the sheath 130.As shown in FIG. 8D, the sheath insert portion may have an approximatelyarcuate cross-section profile, or any suitable profile complementary tothe cross-sectional profile of the sheath to allow the sheath insertportion to be slidingly engaged with the sheath. The sheath insertportion 154 preferably defines an aperture 162 that allows the needle120 to pass within the sheath insert. The aperture 162 may be a roundhole, a slot, or any suitable opening to allow relative longitudinaltranslation of the slider 150 and the needle 120.

The sheath insert portion 154 preferably includes a restraint thatselectively engages with the sheath, such that when the restraint isengaged with the sheath, the restraint reinforces the coupling of thesheath to the medical device, and when the restraint is disengaged fromthe sheath, the restraint weakens the coupling of the sheath to themedical device. In a preferred embodiment, as shown in FIG. 8F, theslider 150, in particular the sheath insert portion 154, may include atleast one restraint tab 151 that is insertable into a restraint slot 138on split portion 140 or jaw 142 of the sheath. In this embodiment, whenthe sheath is retracted and jaws 142 are surrounding and gripping themedical device, the restraint tabs 151 are coupled to the restraintslots 138 and the restraint tabs substantially prevent the jaws frommoving relative to each other, thereby strengthening the grip offlexible jaws 142 on the medical device. When the sheath is extended(e.g. the housing is moved in a proximal direction away from the medicaldevice), the restraint tabs become uncoupled from the restraint slots138, leaving the flexible jaws 142 to more freely move relative toother, thereby weakening the grip of flexible jaws 142 on the medicaldevice. In other words, the selective coupling of the restraint tabs 151on the slider to the restraint slots 138 on the sheath effectivelymodulates the amount of force required to flex the jaws and uncouple thesheath from the medical device.

The slider 150 preferably includes a proximal articulation 164 thatabuts the housing stop and/or a distal articulation 166 that abuts thesheath stop when the sheath 130 is in the extended position. When thesheath 130 is in the extended position, the proximal and distalarticulations preferably fix the slide position relative to both thehousing and sheath, respectively, which indirectly fixes the sheath 130relative to the housing, thereby locking the sheath 130 in the extendedposition. Alternatively, the system may include any suitable lockingmechanism to lock the sheath in the extended position. As best shown inFIG. 8E, the proximal articulation 164 of the slider 150 is preferablyon a proximal portion of the slider and is a laterally outwardextension, such as a tab, that abuts the housing stop. The proximalarticulation 164 may or may not include an aperture similar to theaperture 162 of the sheath insert portion to allow passage of the needle120 through the proximal articulation. The distal articulation 166 ofthe slider 150 is preferably an extension, such as a nub or catch on thesheath insert portion that catches in the aperture 136 of the sheathstop. Alternatively, the distal articulation 166 may be on any suitabledistal portion of the slider. The proximal and distal articulations mayproject towards the bottom of the slider 150, although they may projectin any suitable direction corresponding to the locations of the housingstop on the housing and the sheath stop on the sheath. In othervariations, the proximal and distal articulations may be in any suitablelocations on the slider and may each be an aperture or extensioncorresponding to the kinds of housing stop on the housing and sheathstop on the sheath.

Overall in a preferred embodiment, coupling a distal portion of thesheath to the portion of the medical device involves coupling flexiblejaws (which are extensions of split portions on the sheath) around themedical device. As shown in FIG. 11A, the sheath is preferablyretracted, and restraint tabs 151 on the slider are inserted inrestraint slots 138 on the split portions. While the restraint tabs areinserted the restraint slots, the restraint tabs strengthen or lock thecoupling between the jaws and the medical device, by substantiallypreventing the jaws from moving laterally apart. When the housing andslider are pulled away from the medical device, thereby drawing thesheath over the needle, the distal articulation of the slidertemporarily abuts the first sheath stop 136 so that the restraint tabs151 remain engaged in restraint slots 138 and the sheath remains coupledto the medical device. In this intermediate step, the abutment of thedistal articulation of the slider against the first sheath stop ispreferably overcomes the shear force due to friction between the housingand slider. As shown in FIG. 11C, when the housing is further pulledaway from the medical device, the housing pulls the slider away from themedical device until the distal articulation 166 overcomes first stop136 and abuts the second sheath stop 137, while the proximalarticulation 164 of the slider abuts the housing stop 116. Furthermore,as shown in FIG. 11B, when the distal articulation abuts the secondsheath stop, the restraint tabs 151 disengage from the restraint slots138, thereby weakening the coupling between the jaws and the medicaldevice. For instance, after this final step the user can easily provideenough force to separate the extended sheath (surrounding the needle)and the medical device.

In an alternative embodiment, the slider functions to automaticallytrigger the decoupling between the sheath 130 and the medical devicewhen the needle is withdrawn from the medical device. In thisembodiment, as shown in FIG. 12A, the jaws 142 may be biased into a“closed” configuration 141 in which the jaws tend to grip the matingfeatures on the medical device. As shown in FIG. 12B, the jaws 142 maybe manipulated to flex, swing, or otherwise move into an “open”configuration 143 in which the jaws move laterally apart, therebyenabling decoupling of the sheath 130 and medical device 102, such asafter the sheath has been drawn into its extended position. The jaws 143may be manipulated into the “open” configuration automatically when thehousing and/or slider 150 is pulled in a proximal direction away fromthe medical device, thereby automatically decoupling the sheath 130 fromthe medical device. In this embodiment, as shown in FIG. 13, the slider150 include protrusions 156 that interfere with the flexible jaws of thesheath 130, such that when the slider is withdrawn from the medicaldevice the protrusions 168 trigger the jaws into the “open”configuration, thereby automatically decoupling the sheath 130 and themedical device.

Safety Needle System of a Second Embodiment

In a second preferred embodiment, as shown in FIGS. 14A and 14B, thesafety needle system 200 includes a housing 210 including a needle mount212 coupled to a setting 214 that approximately axially centers theneedle mount 212 within the housing 210; a needle 212 having a distalend insertable through the medical device and a proximal end coupled tothe needle mount 212; and a sheath 230 telescopically engaged with thehousing 210 and having a distal wall 244 defining a needle aperture 246and a longitudinal track 242 that is slidingly engaged with the setting214 of the housing 210. The sheath 230 operates in a retracted position232 in which the sheath exposes the distal end of the needle and anextended position 234 in which the sheath substantially surrounds thedistal end of the needle. Like the sheath of the first preferredembodiment of the safety needle system, the sheath 230 is preferablycoupleable to the medical device such that removal of the needle fromthe medical device draws the sheath 230 over the needle, therebytransitioning the sheath from the retracted position to the extendedposition. The safety needle system preferably further includes a lockingmechanism 250. In a preferred embodiment of the safety needle system,when the sheath is in the extended position, a proximal portion of thesheath 230 abuts a housing stop or catch in the housing, and the lockingmechanism 250 restrains the sheath in the extended position. In onevariation, the locking mechanism 250 is a housing stop including a snaplock cantilevered arm with a free end that is configured to abut theproximal portion of the sheath when the sheath is in the extendedposition. However, any suitable locking mechanism may be used.

The housing 210 of the second embodiment of the safety needle systemfunctions similarly to the housing of the first embodiment of thesystem. As shown in FIGS. 15A-15C, the housing 210 is preferablytubular, defining a channel 216 that telescopically engages the sheath230, and the housing 210 and/or channel 216 is preferably elongated andcylindrical, but may alternatively have any suitable cross-section, suchas an oval or an approximate rectangle. Like the housing in the firstembodiment, the housing 210 of the second embodiment includes a needlemount 212 to which the needle 220 (which is preferably similar to thatof the first embodiment) is coupled. The housing preferably furtherincludes a setting 214 that anchors the needle mount 212 in the housing.The needle mount 212 of the housing is preferably located on a distalend of the housing and is preferably approximately axially centeredwithin the housing. However, the needle mount may alternatively beoffset from the center of the housing, or located in any suitableposition in or on the housing. The setting is preferably a peg,protrusion, or other inwardly, radially extending feature coupled to aninternal wall of the housing. The setting 214 preferably slidinglyengages with the sheath 230 to facilitate assembly and/or operability ofthe sheath in the retracted and extended positions. The setting 214 mayhave any suitable cross-sectional shape to guide the sliding sheath,such as a square or rectangle. Furthermore, the setting 214 may have across-sectional shape that may particularly help reduce lateral movementof the sheath 230 within the housing, such as a dovetail. The housing210 may also have multiple settings arranged within the channel 216 ofthe housing that slidingly engage and guide the sheath. For example, thehousing may have a first setting on one side of the channel to guide anupper side of the sheath 230, and a second setting on an opposite sideof the channel relative to the first setting to guide a lower side ofthe sheath 230. The needle mount 212 is preferably coupled to thesetting 214 such that the setting anchors the needle mount to thehousing, but the needle mount and setting may alternatively beindependent of one another and located in any suitable position in or onthe housing. For example, the setting 214 may be a guide located alongthe same longitudinal line as the needle mount 212, or on an oppositewall of the needle mount 212, or any suitable location. As shown in FIG.15C, the relative dimensions of the needle mount and setting preferablyform an overhang that defines an alcove space 215 or recess between theneedle mount and the housing. The alcove space 215 is preferablydimensioned to accommodate the thickness of the sheath when the sheathis in the extended mode, without permitting the sheath to wobbleextensively within the housing.

In some embodiments, the housing 210 further includes one or morehandles 218 that a user can grip and manipulate to operate the safetyneedle system. The handle preferably includes two side grips on oppositesides of the housing that enable secure grasping with one hand. The sidegrips may be relatively short and narrow along the length of the housing(FIG. 15A) or may be relatively wide and extend along a substantiallength of the housing (FIG. 17A). Like the handle of the first preferredembodiment of the system, the handle 218 may include features such asergonomic contours, ridges to improve friction in the grip, cushioningmaterial such as silicone, or any suitable additions. Furthermore, othervariations of the handle may include fewer or more grips (such as asingle bulbous handle), and may be particular for specific applications.In some embodiments, the handle may further function as a hub cradle,such as for receiving a catheter hub or stabilization hub such as thatdescribed in U.S. patent application Ser. No. 12/855,013, or anysuitable hub or other portion of a medical device.

As shown in FIG. 15C, the distal end of the housing 210 may furtherinclude a ledge 217 that helps support the sheath 230 when the sheath isin the extended position. The ledge 217 preferably extends beyond thedistal end of the housing, preferably on at least an underside of thehousing to support the extended sheath against gravity, and may be flat,curved, or any geometry to support the sheath. The ledge may includeadditional features such as rubberized grips or teeth, or fasteners suchas magnets, clips, or adhesive to help secure or support the extendedsheath. Furthermore, the ledge may be hingedly attached to the housing,such as for folding to make the system more compact during storagebefore and/or after use. However, the ledge may have any other suitablegeometry and/or arrangement.

The sheath 230 of the safety needle system of the second preferredembodiment of the safety needle system functions similarly to the sheathof the first embodiment of the system. As best shown in FIG. 17A, thesheath 230 is preferably slidably engaged with the housing 210 such thatthe sheath passes telescopically within the channel of the housing. Thesheath 230 is operable in at least one of a retracted position 232 inwhich the sheath is at least partially retracted within the housing 210and exposes the distal end of the needle, and an extended position 234in which the sheath 230 is extended from the housing 210 andsubstantially surrounds the distal end of the needle. As shown in FIGS.16-17, the sheath includes a longitudinal track 242 that slidinglyengages with the setting or other portion of the housing, and a distalwall 244 that contributes to covering the distal end of the needle whenthe sheath is in the extended position.

In one preferred embodiment, the sheath 230 is comprised of two pieces,including a proximal sheath portion 230 a and a distal sheath portion230 b. As shown in FIGS. 16A-16E, the proximal sheath portion 230 a andthe distal sheath portion 230 b are assembled to form an integratedsheath body. As shown in FIG. 16E, the proximal sheath portion 230 apreferably includes snap latches 231 a and the distal sheath portionpreferably includes snap holes 231 b that receive snap latches 231 a ina snap fit fastening manner. However, additionally and/or alternatively,the distal sheath portion may include snap latches and the proximalsheath portion may include snap holes, or the proximal and distal sheathportions may be attached by threads, an interference fit, magnets,adhesive, or in any suitable manner. The proximal and distal sheathportions are preferably assembled within the housing 210, joined aroundthe setting and/or other internal projections inside the housing. Duringassembly, the distal sheath portion may enter the housing 210 from thedistal end of the housing and the proximal sheath portion may enter thehousing from the proximal end of the housing. In another variation, thesheath includes one sheath portion and includes features, preferably inthe longitudinal track as described below, that facilitates assemblyinto the housing.

The longitudinal track 242 of the sheath 230 functions to guidetransition of the sheath between the retracted and extended positions.The longitudinal track is preferably a slot, but may alternatively be agroove that slidingly engages the setting, or may include a combinationof single or multiple slots and/or grooves. The longitudinal track 242is preferably substantially parallel to a longitudinal axis of thesheath, from a proximal end of the sheath towards a distal end of thesheath, and slidingly engages with the setting and/or needle mount oranother feature of the housing 210.

As shown in FIGS. 17 and 18, in the one-piece sheath variation, thelongitudinal track preferably includes a series of arcuately offset,adjacent slotted portions, and more preferably two such portions that atleast partially overlap to form a single track of varying width. In apreferred embodiment, as best shown in the “unwrapped” view of the trackin FIG. 17C, the first track portion 242 a runs longitudinally along thesheath 230 from the proximal end of the sheath to a point partiallyalong the length of the sheath. In this embodiment, the second trackportion 242 b is preferably parallel to and circumferentially offset byan offset angle from the first track portion and runs alongsubstantially the entire length of the sheath 230. Each of the two trackportions are preferably approximately as wide, or slightly wider than,the width of the setting of the housing, such that as the sheath 230telescopically moves within the housing 210 with the setting slidinglyengaged with the track 242, the setting 214 freely passes within thelongitudinal track. In a preferred embodiment, the first track portion242 a slidingly engages the setting to allow the sheath 230 to pass in aproximal direction up to the end of the first track portion,particularly to at least partially retract the sheath in the housing,such as during assembly of the safety needle system. The second trackportion 242 b preferably slidingly engages the setting at a differentcircumferential angle around the sheath 230, to allow the sheath to passfarther in the proximal direction towards the fully retracted position.The second track portion 242 b preferably also engages the setting 214to allow the sheath to pass in a distal direction towards the extendedposition of the sheath, such as during use of the safety needle systemto cover the needle. Although the first and second track portionspreferably at least partially share an edge, in other variations thetrack 242 may include any suitable number of track portions in anysuitable arrangement. For example, the first and second track portionsmay be offset by a relatively large offset angle such that the first andsecond track portions do not share an edge. Furthermore, as shown inFIG. 18A, the longitudinal track portions may be joined by a lateraltrack 242 c or other open passageway (such as an open distal end of thesheath as shown in FIG. 18B) so that rotation of the sheath within thehousing enables the setting to travel between the track portions.

As shown in FIGS. 17B, 18A and 18B, the longitudinal track 242 and/orother portion of the sheath 230 preferably also defines a catch portion238 at the proximal portion of the sheath that functions to prevent theextended sheath from fully exiting the housing 210. The catch 238 ispreferably arranged at the proximal portion of the sheath and abuts thesetting and/or needle mount when the sheath is in the extended position.The catch 238 may fit into the alcove space 215 of the housing. Anothercatch mechanism, such as springs or latches, may additionally and/oralternatively be used to prevent the sheath from fully exiting thehousing. In one or more of these variations, the sheath is preferablyrestrained from sliding beyond a particular point in the extension(distal) direction.

The distal wall 244 of the sheath 230 functions to substantially coverthe distal end of the needle when the sheath is in the extendedposition, and further functions as a stop against the needle mountand/or setting when the sheath 230 is in the retracted position, toprevent the sheath from fully retracting into the housing 210. Thedistal wall 244 forms a substantially full or partial face on the distalend of the sheath, and defines a needle aperture 246 or hole largeenough to receive and allow passage of at least a portion of the needle.The needle aperture 246 may be an opening in the distal wall of thesheath (FIG. 18B) or may be in a guide or partial needle covering thatextends beyond the distal wall (FIG. 16). To limit sheath retraction upto a point (such as less than fully retracted within the housing 210,such that the distal end of the sheath is still extending beyond thedistal end of the housing), the distal wall 244 may abut the needlemount and/or setting when the sheath is in the retracted position, oradditionally and/or alternatively the proximal end of the sheath maybutt against a proximal wall or another stop in the housing 210. In atleast one of these manners, the sheath is preferably retraining fromsliding beyond a particular point in the retraction (proximal)direction.

The distal end of the sheath 230 is adapted to mechanically and/ormanually couple to the medical device, similar to the sheath of thefirst preferred embodiment of the system.

The locking mechanism 250 of the safety needle system functions torestrain the sheath 230 in the extended position and prevent the sheathfrom returning from the extended position to the retracted position. Insome embodiments, the safety needle system may include two or morelocking mechanisms in the sheath 230 and/or housing 210. In onevariation, as shown in FIGS. 19A-19D, the locking mechanism 250 may becoupled to the sheath 230 and/or housing 210. For example, the lockingmechanism 250 may be a tab 252, coupled to the sheath, that engages acorresponding catch 254 or other stop in the housing 210 such as nearthe setting and needle mount (or other suitable location in thehousing), to substantially lock the sheath in the extended position. Ina one-piece sheath, the tab 252 is preferably near the proximal end ofthe sheath. In a two-piece sheath, the tab may be located on theproximal sheath portion or the distal sheath portion. The tab preferablyenables passage of the sheath 230 within the housing 210 in a proximaldirection (e.g. only in assembly), while substantially preventingpassage of the sheath in the proximal direction when the tab engages thecatch when the sheath is in the extended position. For instance, asshown in FIG. 19B, during assembly when the sheath 230 is passed in theproximal direction into the housing 210, the sheath may be rotated to aparticular angle such that the setting and/or needle mount preferablydeflect the tab towards the wall of the housing 210, enabling the sheathto free pass in the proximal direction within the housing 210. As shownin FIGS. 19C and 19D, during operation of the safety needle system, whenthe sheath is drawn out to its extended position, a barbed end of thetab engages and stops on the catch of the housing, thereby substantiallypreventing movement of the sheath in the proximal direction andrestraining the sheath in its extended position.

In another variation, as shown in FIGS. 20A-20D, the locking mechanism250 includes a housing stop coupled to the housing 210. In the extendedposition of the sheath 230, the catch of the sheath preferably abuts thesetting or other stop of the housing 210 and the housing stop abuts aproximal face of the catch, thereby trapping the catch between thesetting and the housing stop. The housing stop is preferably a snap lockcantilevered arm or tab on a wall of the housing 210 that is radiallydeflectable inwards (FIG. 20A) and/or have a projection that extendsradially inwards. (FIG. 20B). In other variations, the locking mechanism250 may be a sliding latch (FIG. 20C), lever, (FIG. 20D), push button,or another suitable mechanism that is engageable to trap the catch ofthe sheath 230 against the setting of the housing, thereby locking thesheath in the extended position. In further variations, the lockingmechanism 250 may additionally and/or alternatively abut a distalportion, central portion, or any suitable portion of the sheath. Thelocking mechanism is preferably integrally formed with the housing 210,but may alternatively be a separate piece that is coupled to the housingduring assembly of the safety needle device.

Preferably, the locking mechanism 250 is disengaged or otherwise doesnot interfere with the ability of the sheath 230 to pass in a proximaldirection to its retracted position during assembly of the safetyneedle, or before extended position of the sheath 230 is desired forcovering the needle tip. For example, the free end of the cantilever armmay extend into the alcove space 238 adjacent to the setting of thehousing 210 out of the assembly path of the sheath, such that duringassembly the cantilever arm does not accidentally abut the catch of thesheath 230 and prematurely lock the sheath in the extended position. Inother variations, the locking mechanism may be selectively disengagedaccording to its mechanical nature, such as by sliding a latch orpivoting a lever out of the way of the sheath when the sheath is to beretracted (e.g. during assembly or if the needle is to be uncovered).

In either preferred embodiment, the safety needle system may furtherinclude a protective cap 260 that covers the distal end of the needleprior to use of the safety needle system or whenever the sheath is inthe retracted position, such as during transport or storage. Theprotective cap 260 may be a sleeve that surrounds at least a portion ofthe exposed needle, and/or include a blunt stopper that occludes orblunts the distal end of the needle. However, any other suitable type ofcap may be used.

As shown in FIGS. 21A-21D, the method of assembling the safety needlesystem 300 of the second embodiment includes: inserting a proximal endof the sheath into a distal end of the housing S310; engaging thesetting of the housing within the first track portion of thelongitudinal track S320; sliding the sheath telescopically to at least apartial retracted position in the housing S330, with the setting of thehousing traveling within the first track portion of the longitudinaltrack; rotating the sheath within the housing by the offset angle S340to engage the setting of the housing within the second track portion ofthe longitudinal track; and sliding the sheath into a full retractedposition in the housing S350, with the setting of the housing travelingwithin the second track portion of the longitudinal track. As shown inFIG. 21E, the method may also include sterilizing the needle and/orplacing a protective cap S360 onto a distal end of the needle that helpsmaintain sterility and protect users from accidental needle pricksduring transport and storage. This method may be used to assemble anembodiment of the safety needle system with a one piece sheath, but avariation 300′ may similarly be used to assemble a safety needle systemwith a sheath having two or more pieces. In another variation 300′, toassemble a two-piece sheath variation of the system, the proximal sheathportion and the distal sheath portion are preferably coupled to oneanother around the setting or other housing stop of the housing. Forinstance, method 300′ may include inserting the proximal sheath portioninto the proximal end of the housing S370, inserting the distal sheathportion into a distal end of the housing S380, and coupling the proximalsheath portion and distal sheath portion to one another S390, preferablyaround the setting. After assembly, the sheath is preferablyapproximately concentrically nested within the housing. The safetyneedle system may be assembled during manufacture and supplied to theuser with the sheath in its retracted position, or with the sheath inits extended position. Alternatively, the safety needle system may beassembled by the user prior to use.

Safety Needle System—Septum

In either preferred embodiment, the safety needle system may furtherinclude one or more instances of a septum 400 that functions to seal anybody fluids, such as blood, or other potential biohazards within thesheath as the sheath passes over the needle into the extended position,as the needle is withdrawn from the medical device. Although the safetyneedle system with septum is primarily shown with the system of thefirst preferred embodiment, the second preferred embodiment of thesystem may also include a septum 400. The septum 400 is preferablycoupled to the sheath 130 and more preferably within the sheath. Theseptum 400 in the safety needle system is configured to couple to themedical device (e.g. a septum in the catheter hub or other portion ofany medical device) in a fluid-tight manner, to help prevent fluidleakage through the joint between the medical device and the safetyneedle system. For example, the end of the safety needle system septummay be circumferentially enclosed by the medical device, or the medicaldevice may be circumferentially enclosed by the safety needle systemseptum. As another example, the joint between the safety needle systemand the medical device may include a fluid-tight butt joint or othersealant.

As shown in FIG. 23, the septum preferably includes a first seal 410 anda second seal 420. The first seal 410 is a defense against fluidescaping from one end of the septum, and the second seal 420 functionsas a defense against fluid escaping from another end of the septum. Insome embodiments, the septum 400 may include fewer or more seals similarto the first and second seals, which may be suitable for someapplications to modify the amount of fluid leakage protection. Theseptum 400 preferably defines a cavity 414 between the first and secondseals that may contain trapped fluid. The cavity 414 may be larger thanthe diameter of the needle to reduce frictional force as the septumpasses over the needle. However, the cavity may alternatively be closelyfit over the needle, and/or include a material with a lower frictioncoefficient and/or fluid absorbent material. As shown in FIGS. 24-26,the septum length, and more preferably the cavity length, is at least along as the notch extent distance of the needle and positioned as suchthat when the sheath is in the extended mode, the notch is fullycontained within the septum. In some embodiments, the needle may includeadditional fluid exit points such as multiple notches along its length,and the safety needle system may include a longer septum or multiplesepta to contain the multiple fluid exit points on the needle.

As shown in FIGS. 24A and 24B, the safety needle septum 400 may beshorter than the length of the sheath 130, such as near the distal endof the sheath so that when the sheath is in the extended position, theseptum contains a portion of the needle body including the distal end ofthe needle and the notch. Alternatively, the safety needle septum may beat least substantially the same length as the sheath. For example, asshown in FIGS. 25A and 25B, the septum may be nearly the same length asthe sheath such that when the sheath is in the extended position, theseptum contains a large portion needle body. In another example, asshown in FIGS. 26A and 26B, the sheath and septum may be at least aslong as the notch extent to contain the notch, but shorter than theoverall needle length.

The septum 400 may include an elastomeric material, and may have adiameter slightly larger than the diameter of the sheath, such thatcompression of the septum, when assembled in the sheath, seals theannular gap between the outer circumferential edges of the septum andthe walls of the sheath, thereby preventing fluid from escaping throughthe annular gap, and further maintaining the coupling between the septumand the sheath, similar to a press fit. The septum may additionallyand/or alternatively include a sealant material applied between theouter surface of the septum and the sheath, and/or be temporarily orpermanently bonded to the sheath such as with sonic welding, chemicalwelding, or adhesive.

As shown in FIGS. 27A-27D, in a preferred embodiment of the septum, theseptum 420 includes a rigid core 422 and a compressible plug 428 coupledto the rigid core 422. The rigid core 422 is a framework that preferablyincludes a back wall 424 with aperture 426 and wall members 425extending from the back wall. The back wall 424 may provide a flangethat helps seat the septum 420 within the sheath 130. The wall members425 are preferably substantially parallel, but may be in any suitablerelative orientation that defines a gap between the wall members. Thecompressible plug 428 is coupled partially or wholly around the rigidcore 422, covering or filling the aperture 426 and surrounding the wallmembers 425 to define a cavity 414in a central portion of the septum.One end of the compressible plug 428 forms the first seal 410, and theother end of the compressible plug covering the aperture of the backwall forms the secondary seal 412. The aperture 426 of the back wallallows needle puncture access through the rigid core into the septumcavity. The rigid core is preferably made of a rigid plastic such aspolycarbonate, acrylonitrile butadiene styrene (ABS) or other styrene,and the compressible plug preferably includes an elastomeric materialsuch as isoprene or silicone. However, the rigid core and compressibleplug may include any suitable materials. The compressible plug ispreferably coupled to the rigid core in an overmolding manufacturingprocess, but may additionally and/or alternatively include othercoupling mechanisms such as adhesive.

In a first alternative variation, as shown in FIGS. 28A-28C, the septumis a split septum 430 that includes a split 432 along a portion of itslength. The split longitudinally divides the septum into approximatelytwo halves or other multiple portions. The split 432 may begin at thesecond seal 412 and terminate near the inner face of the first seal 410,such that the split travels along at least half of the length of theseptum and is joined near the first seal, but the split 432 mayalternatively be any suitable length, including along the entire lengthof the septum such that the septum includes two separate portions. Asshown in FIG. 28C, when the septum is assembled into the sheath, thesheath preferably radially compresses the septum material to close thesplit, thereby forming the cavity and the second seal. The split septummay be manufactured through injection molding, such as with a moldhaving a cavity as shown in FIG. 28B. In another example of thisvariation, the split 432 may begin at the first seal and terminate atthe second seal. In yet another example of this variation, the septummay be split longitudinally along two or more lines, forming three ormore split portions.

In a second alternative variation, as shown in FIGS. 29A and 29B, theseptum is a dual grommet septum 440 that includes at least two septumpieces 442 or “grommets” placed serially within the sheath. One of theseptum pieces 442 forms the first seal 410 and another septum piece 442forms the second seal 412. The septum pieces are preferably immediatelyadjacent to each other such that part of their interior faces arecontacting and form a fluid-tight seal against the sheath. The interiorfaces of the septum pieces may be chamfered or radiused to define theseptum cavity 414 between the septum pieces, but the septum pieces mayalternatively have any suitable geometry. Alternatively, the septumpieces may be separated by a distance, such that the septum cavity is atleast partially formed by the walls of the sheath 130. In other examplesof this variation, the septum may includes three or more septum piecesplaced serially within the sheath, such as to provide three or moreseals.

In a third alternative variation, as shown in FIGS. 30A and 30B, theseptum 450 includes at least two separate septum pieces 452 and an innersleeve 454 disposed between the septum pieces. In this variation, twoseptum pieces 452 are placed serially within the sheath 130, eitherdirectly adjacent to each other or separated by a distance. One of theseptum pieces 452 forms the first seal 410 and another septum piece 452forms the second seal 412. The interior faces of the septum pieces arepreferably adapted to receive the inner sleeve 454, such as by definingaxially aligned recesses. The inner sleeve 454 may be cylindrical andsized to fit within the recesses of the septum pieces, with an innerdiameter large enough to form a cavity that accommodates the diameter ofthe needle. The inner sleeve is preferably rigid, and made of athermoplastic material or any other suitable rigid material, althoughthe inner sleeve may be made of any suitable material. In other examplesof this variation, the septum may include more than two septum pieces,such as further including an outer sleeve-like septum part surroundingthe inner sleeve.

In a fourth alternative variation, as shown in FIGS. 31A-31E, the septum460 includes a housing with first and second housing portions 464 andfirst and second septum pieces 462. In this variation, as shown in FIG.31E, the septum includes a first half and a second half that issubstantially a mirrored version of the first half, with each halfincluding a housing portion 464 and a corresponding septum piece 462. Asshown in FIG. 31A, each housing piece 464 includes a tapered,hourglass-shaped chamber 466 for receiving a corresponding septum piece.The taper in the chamber helps reduce relative movement such astranslational movement between the septum piece and the housing. Eachhousing piece may further include an external annular flange 468 orother protrusion that helps reduce translational movement between thehousing and the sheath. The two housing pieces 464 may be coupledtogether and/or to the sheath 130 through ultrasonic welding, epoxy orother adhesive, threads, and/or any suitable coupling mechanism. Asshown in FIG. 31D, each septum piece preferably includes a cavity 463that extends inward from one open end of the septum piece, and theseptum pieces are preferably assembled such that the open ends of theseptum pieces abut against each other. In this manner, as shown in FIG.31E, the closed ends of the septum pieces form first and second seals,respectively, of the septum, and the joined open ends of the septumpieces form enclosed septum cavity 414. The housing and septum piecesare preferably combined, with a corresponding septum portion nestedwithin (e.g. molded into or pressed into) each housing portion, and thecombined housing and septum pieces are preferably mounted within thesheath.

In an alternative embodiment, the septum 400 may have only one seal. Ina first alternative variation of this embodiment, the septum is made ofa flexible material that self-seals to form a hermetic seal within thesheath. This self-sealing septum prevents fluid from passing out of thesheath, contributing to a closed system in which blood and other fluidswill not exit the sheath after the needle is contained inside the sheathin the extended position. In a second alternative variation, the septummay be sealed with a plug, such as a stopper or sealant material appliedto the septum by a user. The plug may include a separate stopped plugapplied to the distal end of the sheath, a sliding piece that the userslides to gate off the distal end of the sheath, a hinged piece that theuser swings over the distal end of the sheath, and/or any suitableseptum piece. Any of these single seal variations of the septum may berepeated serially to form two seals or more seals.

The septum may be one or more of the embodiments and variationsdescribed above, and/or one or more of the embodiments described in U.S.Provisional Applications 61/346,292 filed 19 May 2010 and 61/407,797filed 28 Oct. 2010, which is each incorporated in its entirety by thisreference. Furthermore, the septum may be any suitable mechanism thathelps prevent escape or leakage of fluid from the sheath.

In either preferred embodiment, as shown in FIG. 32, the safety needlehousing 110 may additionally and/or alternatively include a vent chamber470 and a vent cap 472 that seals one end of the vent chamber. The ventchamber 470 may be coupled to the needle mount, such that the ventchamber receives blood or other body fluids through the needle. In onevariation, the vent chamber includes a recess within the needle mount ofthe housing, and the proximal end of the needle is inserted into anentrance of the vent chamber to carry fluids into the vent chamber. Inthis variation, the interface between the needle and the vent chamber issealed to further guard against release of fluids, such as with afilter, gasket, O-ring, epoxy, or any suitable seal material ormechanism. Furthermore, the housing may include a vent cap 472 thatseals one end of the vent chamber to prevent passage of fluid throughoutthe rest of the housing and safety needle system. The vent cap ispreferably hydrophobic, preventing fluid from exiting the vent chamberwhile allowing air to exit the vent chamber, thereby creating a pressuredifferential across the needle body due to the difference betweenvascular and atmospheric pressures. This pressure differential causesthe blood in the needle to “flash back” into the vent chamber. Inanother variation, the proximal end of the needle includes an enlargedneedle chamber volume that receives fluids, and the vent chamber of thehousing receives the needle chamber. In this variation, the fluids arecontained within the needle structure, which is in turn mounted in thehousing.

In either preferred embodiment, the safety needle system may furtherinclude a catch 480 that helps lock the septum 400 (or alternatively aportion of the sheath 130 without a septum) in place over the notch 122and/or the distal end of the needle 120. The catch 380 may additionallyand/or alternatively fix the sheath in the extended position. As shownin FIGS. 33A and33B, in one variation the catch may be coupled to aninternal portion of the septum, such as a spring clip within the septumcavity (or other portion of the septum or sheath) that engages theneedle once the sheath is in its extended position. When the spring clipengages the needle, the spring clip prevents movement of the sheath in aproximal direction, thereby locking the septum in place. As also shownin FIGS. 33A and 33B, in another variation the catch is a compressiblering 484 or nub on an external surface of the needle 120 that compresseswhen the septum 400 passes over the catch in a distal direction, andexpands again when the septum covers the notch and/or distal end of theneedle, thereby preventing movement of the sheath in a proximaldirection and locking the septum in place.

Method of Using the Safety Needle System

As shown in FIGS. 34-40, the method 500 of using the safety needlesystem of the embodiments described above with a medical device, such aswith a catheter hub, preferably includes: inserting the needle into apatient S510; coupling a distal portion of the sheath to the medicaldevice S520, pulling the housing away from the medical device S530 in aproximal direction relative to the needle; allowing the sheath to slidein a distal direction towards the extended position S540, therebydrawing the sheath into the extended position; locking the sheath in theextended position S550, and uncoupling the distal portion of the sheathfrom the medical device S560.

Inserting the needle into the patient S510 preferably includes anysuitable steps for particular applications, such as threading a catheterover the needle into a blood vessel and drawing blood through theneedle. These steps are common and are familiar to one skilled in theart, although any suitable insertion step may be used. As shown in FIG.34, the step of inserting the needle into the patient may furtherinclude inserting the needle through a portion of the medical device,such as a catheter hub.

In one embodiment, as shown in FIGS. 34, 35A and 35B, coupling a distalportion of the sheath to the portion of the medical device includesmechanically coupling the sheath to the medical device S522. In onevariation, mechanically coupling the sheath to the medical deviceincludes seating a portion of the medical device within the distalportion of the sheath, such as surrounding or gripping a portion of themedical device with flexible jaws S523 or receiving a feature of themedical device in a receptacle of the sheath S522. In another variation,mechanically coupling the sheath to the medical device S522 includesseating the distal end of the sheath in a receptacle of the medicaldevice S526. In other variations, mechanically coupling the sheath tothe medical device includes manipulating snaps, latches, tabs and slots,magnets, or any suitable fastener.

In another embodiment, as shown in FIG. 35C, coupling a distal portionof the sheath to the portion of the medical device includes manuallycoupling the sheath to the medical device, which may include manuallypressing a holding tab (or other finger rest, extension, or otherportion of the sheath) of the sheath over the medical device. In othervariations manually coupling the sheath to the medical device mayinclude any suitable manual coupling step.

As shown in FIG. 36, pulling the housing away from the medical deviceS530 initiates allowing the sheath to slide in a distal directiontowards the extended position. Pulling the housing away from the medicaldevice includes maintaining the coupling between the sheath and medicaldevice, although in a preferred embodiment, the coupling between thesheath and the medical device may be weakened after the sheath is in theextended mode, thereby lowering the required amount of force to separateor decouple the sheath and the medical device. As also shown in FIG. 36,allowing the sheath to slide in a distal direction towards the extendedposition S540 includes drawing the sheath into the extended position. Inone embodiment, as shown in FIG. 37, allowing the sheath to slide in adistal direction includes drawing a septum over the needle S542, whichallows the sheath to contain fluid leakage from the needle. When thesheath is in the extended position, the septum preferably encloses thedistal tip of the needle and the notch (if present). Steps S530 and S540are preferably performed approximately simultaneously, but mayalternatively be performed separately and sequentially.

Locking the sheath in the extended position S550 may be one of more ofseveral variations. In one variation, such as with the safety needlesystem of the first embodiment as shown in FIGS. 38-38C, locking thesheath S550 includes longitudinally wedging a slider between theextended sheath and the housing S552. Wedging the slider S552 preferablyincludes coupling a proximal end of the slider to the housing S554 andcoupling a distal end of the slider to the sheath S556, therebypreventing relative longitudinal movement between the sheath and thehousing. In another variation, as shown in FIG. 39A, locking the sheathS550 includes allowing a locking mechanism to abut a proximal portion ofthe sheath against a stop S557. For example, a snap lock cantilever armon the housing may abut the catch of the sheath against the setting ofthe housing, thereby trapping the catch in the alcove space adjacent tothe setting. In a third variation, as shown in FIG. 39B, locking thesheath S550 includes allowing the sheath and needle to engage with acatch S558. The catch may be coupled to the sheath and engage with theneedle (e.g., a spring clip within the septum or other portion of thesheath), and/or the catch may be coupled to the needle and engage withthe sheath (e.g. a compressible ring around an external surface of theneedle). However, locking the sheath in the extended position mayinclude any suitable step.

Uncoupling the distal portion of the sheath from the medical device S560includes reversing the mechanical or coupling step performed whencoupling the distal portion of the sheath to the medical device.Uncoupling may include unseating the medical device from within thesheath, unseating the sheath from the medical device, releasing a manualholding force coupling the medical device and sheath, or any suitablestep. In some embodiments, the interaction of the sheath, slider, andhousing triggers automatic decoupling of the sheath from the medicaldevice. Following the uncoupling step, the needle is contained withinthe extended sheath and the safety needle system is fully disengagedfrom the medical device.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the preferred embodiments of the invention withoutdeparting from the scope of this invention defined in the followingclaims.

We claim:
 1. A safety needle system operable with a medical device,comprising: a housing including a needle mount; a needle having a distalend insertable through the medical device and a proximal end coupled tothe needle mount; a sheath telescopically engaged with the housing andcircumferentially surrounding at least a portion of the needle, whereinthe sheath operates in: a retracted position, wherein the sheath exposesthe distal end of the needle; and an extended position, wherein thesheath substantially surrounds the distal end of the needle; wherein thesheath is coupleable to the medical device such that removal of theneedle from the medical device draws the sheath over the needle, therebytransitioning the sheath from the retracted position to the extendedposition; and a slider, longitudinally engaged with at least one of thehousing, sheath, and needle and including a restraint that selectivelyengages the sheath, wherein: when the restraint is engaged with thesheath, the restraint reinforces the coupling of the sheath to themedical device; and when the restraint is disengaged from the sheath,the restraint weakens the coupling of the sheath to the medical device.